Recall Z-1682-2025 ยท FRN Pump, Infusion
Smiths Medical ASD, Inc.
CADD Solis VIP Ambulatory Infusion Pump Models: 1) PUMP KIT, CADD-SOLIS VIP, MDL 2120, NA ENGLISH, MANUAL MODE, 1/EA, Model Number: 21-2127-0105-01; 2) PUMP KIT, CADD-SOLIS VIP, MDL 2120, NA ENGLISH, PHARMGUARD ENABLED, 1/EA, Model Number: 21-2120-0105-01; 3) PUMP KIT, CADD-SOLIS VIP, MDL 2120, NA ENGLISH 1/EA, Model Number: 21-2120-0103-01; 4) PUMP, CADD-SOLIS VIP, MDL 2120, ENGLISH
| Date | May 5, 2025 (initiated Apr 10, 2025) |
| Status | Open, Classified |
| Reason | There is a potential for thermal damage in CADD-Solis and CADD- Solis VIP infusion pumps. |
| Root cause | Under Investigation by firm |
| Action | An URGENT MEDICAL DEVICE CORRECTION dated 4/10/25 was sent to customers. Actions for Users: Inform all affected CADD-Solis and CADD-Solis VIP users of this notice. Provide the instructions below: 1. Ensure all users or potential users of these products are immediately made aware of this notification. 2. Upon receipt of this notification and ongoing during regular maintenance, visually inspect the external condition of the battery pack or Wireless Communication Module and look for evidence of any physical damage. Handle a damaged device with caution. As stated in the battery pack Instructions |
| Quantity | 313,676 items |
| Distribution | Worldwide - US Nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K111275 | CADD SOLIS VIP AMBULATORY INFUSION PUMP AND CADD SOLIS MEDICATION SAFETY SOFTWARE Smiths Medical Asd, Inc., Feb 1, 2013 |